Risk management and usability are some of the highlights in the new version of ISO 13485, which was revised earlier this year.
In terms of design specifications, the new version of 13485 features an increase in the requirements on risk management, said Kim Trautman, NSF Health Sciences’ executive vice president, medical device international services.
The new version of ISO 13485, published first in 1996 and revised in 2003, was officially released March 1.
In the 2003 version, risk management played a much smaller role, focusing mainly on product design.
ISO 13485 outlines a comprehensive quality management system for the design and manufacture of medical devices. The revision represents a significant update to the overall quality management process, bringing it in line with current industry practices.
“As regulators have developed over the past 20 years, risk management has played a much more vital part, in part because we as industry have become so global, and in becoming so global everybody can’t be everywhere and be everything to everybody and every product. There are decisions that have to be made, and they have to be made on good science and on good risk decisions,” Trautman, who is also FDA’s former associate director for international affairs, said during FDAnews’ Medical Device Quality Congress on March 16.
Usability is another area in which regulatory expectations have moved in ISO 13485, she added. Back in 1996, the FDA issued guidelines on design that referred to “human factors,” but today the term of art is “usability.”
Earlier this year, the FDA issued final guidance on Applying Human Factors and Usability Engineering to Medical Devices, shedding light on the factors that companies should consider when developing devices to eliminate or reduce design-related problems that contribute to or cause unsafe or ineffective use.
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